BD (Becton, Dickinson and Company) Clinical Quality and Compliance Manager in Franklin Lakes, New Jersey

Job Description Summary

Job Description

The Senior Clinical Quality and Compliance Manager is responsible for leading activities that result in being an organization that is “Audit Ready”. The individual will report directly to the Director Clinical Quality and Compliance. The primary responsibilities include: Leading the Clinical Quality Assurance Program, Supporting Vendor qualification and management activities, investigation of high risk quality concerns, and providing interpretation and application of current and upcoming regulations in the industry.

Essential Job Functions:

  • Develops and executes risk based quality assurance strategies to support the Global Clinical Operations activities, which include assessment / audit planning, conduct, documentation and follow up of planned activities

  • Maintains knowledge of FDA and other regulatory agencies’ (e.g., European agencies) activities, regulations and guidelines relevant to Clinical Affairs

  • Monitors relevant agency compliance rulings and communications

  • Provides expertise and guidance to collaborating departments in interpreting and implementing government and agency guidelines to assure GxP compliance

  • Takes the lead role in supplier/vendor qualification and compliance oversight process

  • Develops, implements, and executes the GxP compliance auditing program to ensure the fulfillment of regulatory requirements

  • Reviews and monitors Corrective Action Plans identified internally and/or externally and assist in root cause analysis and formulating responses

  • Supports regulatory inspections of Sponsor, GCP sites and GxP vendors

  • Supports the Quality Planning Process and risk profiling activity & mitigation approaches during the study life-cycle

  • Supports the management of quality systems & continuous improvement.

  • Interacts and develops relationships with vendors’ quality leaders through audits, project teams, and established one-on-one relationships

  • Writes GxP Quality SOPs in support of the Clinical Quality Systems

  • Ensures compliance with corporate policies and procedures as well as US healthcare laws and regulations through ongoing assessments during the conduct of studies

  • Identifies additional capacity needs in the audit activity, assist in sourcing, and train incumbents on internal SOP’s related to the audit program

  • Develops and maintains of written internal procedures for clinical assessments and associated templates

  • Produces training material and conduct training sessions regarding compliance to policies, procedures, standards and regulations

  • Participates in external committees (e.g., AdvaMed) as requested

Basic Qualifications:

  • Bachelor’s Degree required preferably in the sciences or engineering

  • Minimum 8 years medical device and/or pharmaceutical experience in clinical or quality systems, preferably with significant device experience in Clinical Affairs

  • Knowledge and understanding of clinical development programs and clinical trial processes as well as quality management systems and quality control tools

  • Minimum 5 years performing supplier/vendor qualifications and audits

  • Advanced knowledge of and experience of with all regulations, and relevant standards (e.g., FDA, ISO, MDR, IVDR GDPR)

Additional Desirable Qualifications Skills and Knowledge:

  • Knowledge of and experience with O-US country related regulations

  • Knowledge of processes related to Clinical Affairs Data Management and Biostatistics functions

  • Experience in Regulatory Affairs and/or Quality department

  • ASQ certification, IRCA or other relevant auditor certification a plus

  • Effective communication skills both verbal and written

  • Ability to work independently with minimal supervision and accountable for managing multiple studies concurrently

  • Demonstrates leadership abilities

  • Establishes rapport and collaborates with other (internal and external) team members; builds constructive and effective relationships

  • Anticipates problems, issues, and delays; proactively looks to minimize the impact of identified compliance issues

  • Multi-disciplinary knowledge across functional areas

  • Position eligible to work remote

Primary Work LocationUSA NJ - Franklin Lakes

Additional Locations

Work Shift

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status